Risk Minimisation

CIOMS Working Group IX on “Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management”

CIOMS Working Group IX was created in April 2010 based on suggestions from a number of drug regulatory authorities and pharmaceutical companies. The overall objective of the efforts of this Working Group is to consolidate concepts of risk management tools and propose their application in order to harmonize views and globally protect public health, and to positively impact prescriber-patient interactions.

Risk management tools have evolved in an uncoordinated manner in different regulatory jurisdictions, and risk management systems with different concepts and sets of pharmacovigilance activities have been introduced. There are several tools that support the life-cycle process of biopharmaceutical product development, and a need has been defined for a harmonized risk management toolkit, providing outlines for content and usage of the toolkit, and describing the steps for its development and maintenance as the science of risk management evolves.

CIOMS Working Group IX is to develop a pragmatic consensus publication that would contain a harmonized list of tools for managing the risks of medicinal products intended for human use, as well as considerations governing the potential application of these tools. Consultation with stakeholders, including patient groups, has been promoted by members of the Working Group during the development of the CIOMS IX recommendations.